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CERTIFICATE OF ANALYSIS
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Product Name |
Troxerutin （EP9.0） |
Batch No. |
20230108 |
|
MFG. Date |
08/01/2023 |
EXP. Date |
07/01/2025 |
|
Batch Quantity |
1000kg |
CAS no |
7085-55-4 |
|
ITEMS |
SPECIFICATIONS |
RESULTS |
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Appearance |
Greenish yellow or yellow fine powder |
Greenish yellow or yellow fine powder |
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Solubility |
Freely soluble in water, slightly soluble in ethanol(96%) and practically insoluble in methylene chloride |
Complies |
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Identification |
(A)IR (B)HPLC |
Complies |
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-principal Peak:Tris(hydroxyethyl)rutin |
≥80% |
83.13% |
|
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-Any other peak |
For each peak,maximun 5%,except for 1 peak which can be maximun 10% |
Complies |
|
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Tetrakis(hydroxyethyl)rutin |
4.98% |
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Mono(hydroxyethyl)rutin |
1.19% |
||
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Bis(hydroxyethyl)rutin |
4.45% |
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Loss on drying (130℃) |
≤5.0% |
4.55% |
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Melting point |
168℃～176℃ |
170℃～172℃ |
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Sulfated ash |
≤0.4% |
0.08% |
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Residue on ignition |
≤0.1% |
0.05% |
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Ethylene oxide |
≤1ppm |
0.7ppm |
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Assay （UV） |
95.0～105.0% |
98.4% |
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Methanol |
≤3000ppm |
706ppm |
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Particle size |
100% pass through sieve 80 mesh |
100% pass 80 mesh |
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Total plate count |
≤1000cfu/g |
130cfu/g |
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Yeast & mould |
≤100cfu/g |
20cfu/g |
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E.Coli |
Absent |
Absent |
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salmonellae |
Absent |
Absent |
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Staphylococcus Aureus |
Absent |
Absent |
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Conclusion |
The test results conform to EP9.0 |
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